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The HDI 1000 system is intended for opthalmic, fetal (OB/GYN), abdominal, intraoperative (abdominal organs, vasuclar, neurological,) pediatric, small organ, musculoskeletal (conventional, superficial,) neonatal cephalic, adult cephalic, cardiac, transrectal, transvaginal, and peripheral vessel indications for use. Typical examinations shall include: - General abdominal and pelvic studies including organ surveys and retroperitoneal cavity studies. - Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall. - Pediatric scans of organs. . - Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. - Monitoring procedures for infertility applications. . - First, second and third trimester pregnancy studies. . - Prostate, prostate biopsy guidance, and rectal wall studies. . - Neonatal cephalic studies. . - Transcranial studies of middle cerebral arteries, internal carotid artery, . and vertebral arteries. - Cardiac studies in adults and children. . - Biopsy guidance for tissue or fluid sampling. . - Ophthalmic studies of the eye and surrounding structures and studies to . obtain blood flow information in the eye and surrounding structures. - Conventional and superficial musculoskeletal studies. .

This 510(k) adds the musculoskeletal applications (superficial and conventional) to the HDI 1000 system. The HDI 1000 system is a general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical values related to potential bioeffect mechanisms. The HDI 1000 system functions by acquiring ultrasound data and displaying it on a monitor in 2-D, M-mode, 2-D Color Flow Doppler, Color M-mode, Color Power Angio, Pulsed (PW) Doppler or in a combination of modes. An audio presentation of pulsed Doppler information is also available on the systems. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes. The HDI 1000 system is designed to accept a large selection of scanheads with up to two being connected to the system at any one time. The operator may select between the two scanheads by means of a control located on the system control panel. All actions affecting the performance of the scanhead are activated from the main system control panel. The HDI 1000 system is designed to accept scanheads of the following types and frequency: frequency range: 2.0 - 11.0 MHz scanhead types: flat linear array, curved linear array, phased array Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as field of view, focal depth, image quality, power etc.

Atlas 2.0 / Hitachi 2.0 are intended for cardiac, peripheral vascular, feval imaging and other, and ophthaimic intended uses as defined FDA guidance documents. Typical examinations shall include: - General abdominal and pelvic studies including organ surveys and retro-peritoneal cavity studies. - Study of small parts including breasts, penis, testes, thyroid/parathyroid and the abdominal wall. - Pediatric scans of organs. - Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery. - Monitoring procedures for infertility applications. - First, second and third trimester pregnancy studies, - Prostate, prostate biopsy guidance, and rectal wall studies. - Neonatal cephalic studies. - Transcranial studies of middle cerebral aneries, internal carotid artery, and vertebral . arteries. - Cardiac studies in adults and children. . - Biopsy guidance for tissue or fluid sampling. - Ophthalmic studies of the eye and surrounding structures and studies to obtain blood flow information in the eye and surrounding structures.

Atlas 2.0 / Hitachi 2.0 are general purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-scroen display for thermal and mechanical values related to potential biocffect mechanisms. There function is to acquire ultrasound data and display it on a monitor in 2-D, M-mode, 2-D Color Flow Doppier, Color M-mode, Color Power Angio, Pulsed (PW) Doppier or in a combination of modes. An audio presentation of pulsed Doppler information is also available on the systems. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnostic purposes. The Atlas 2.0 / Hitachi 2.0 systems are designed to accept a large selection of scanheads with up to two being connected to the system at any one time. The operator may select between the two scanneads by means of a control located on the system control panel. All actions affecting the performance of the scanhead from the main system control panel. The Atlas 2.0 / Hitachi 2.0 system is designed to accept scanneads of the following types and frequency: frequency range: 2.0 - 10.0 MHz scanhead types: fiat linear array curved linear array phased array Specific operating conditions (frame rate, line density, center frequency, number of active clements etc.) are automatically optimized by the system software in response to user inputs such as ficld of view, focal depth, image quality, power etc.